Clinical Research Administrator Job in Tampa 33601, Florida Us
Clinical Research Administrator
Department: Pediatrics
Campus: University of South Florida Tampa Campus
Serves as liaison between the Research Base and members (CCOP/MBCCOP/Direct Affiliates), between the Research Base and federal agencies (NCI, FDA, etc.) and vendors (e.g. LabCorp). Frequent contacts with members to keep them aware of ongoing study progress, new concepts and protocol amendments. Participates in development of concepts/protocols and related documents. Coordinates submission of and tracks review of protocol with the NCI. Works with statistician and research computing to develop study databases prior to study activation, including study forms development. Plans patient registration and randomization procedure, ensuring that automated systems are functional by the time the study is ready to begin accrual. Ensures that NCI approved protocols are submitted to required IRB's) and that annual continuation criteria are met. Document compliance of CCOP investigators with federal requirements (forms on file, mandatory education completed, etc.). File required NCI reports within required time frame. Monitors and reports accrual from participating CCOP's. Determines efficient method of data flow from participating CCOPs to the Operations Center; monitors data quality; generates data queries and track responses. Provides data delinquency/quality report to project PI, project administrator, protocol PI, CCOP PI and responsible site coordinators. Responsible for assisting in the interpretation and implementation of policies and procedures (federal/local) as they apply to assigned areas of responsibility. May recommend changes on policy/procedures as necessary. Provides reports to NCI, FDA and other regulatory organizations as required.
Qualified candidates are encouraged to apply online at:
employment.usf.edu/applicants/Central?quickFind=55102
USF is an EO/EA University